vinodvasala
☆    

India,
2021-04-13 13:27
(30 d 16:39 ago)

Posting: # 22307
Views: 1,457
 

 Retention samples [Regulatives / Guidelines]

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Hi Sir,

Could you please tell me what is the retention sample for USFDA, Canada, EC, WHO and Anvisa for BA&BE studies
 
dshah
★    

India,
2021-04-13 19:07
(30 d 10:59 ago)

(edited by dshah on 2021-04-13 19:19)
@ vinodvasala
Posting: # 22308
Views: 1,173
 

 Retention samples

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Dear Vinodvasala!

Please search in forum for previous discussions  ,  ,  . In general as per Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)- 30 units for Drug Products Manufactured in Single-Dose Units or 3 units for Drug Products Manufactured in Multi-Dose Units for US regulatory and 300 units for 5X testing (safer approach).
Regards,
Dshah
 
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